The perivaginal muscle structure consists primarily of two separate and distinct muscle groups, the sphincter muscles and the pelvic floor or pubococcygeus (PC) muscles. The PC muscles are elongated strands of muscle extending between the inner regions of the pelvic bone, supporting the perimeter of the vagina. This particular muscle configuration is commonly referred to in the medical community as having the appearance of hammocks having the ends attached to the pelvic bone inner perimeter while the middle portion of the hammocks overlays the exterior perimeter of the vagina. The sphincter muscles and the PC muscles operate in conjunction to constrict the opening and closing of the urethra, vagina, and rectum. When the pelvic floor muscle tone is good, these openings are properly maintained and constricted by virtue of the tightness of the muscles surrounding the respective openings. However, numerous factors cause or significantly contribute to the deterioration of the perivaginal muscle structure and the subsequent enlarging and relaxing of the aforementioned openings. The primary factors contributing to weakened perivaginal muscle structure are childbirth, over medicating, poor physical conditioning, auto accidents, surgical procedures, progressive illnesses, and atrophy associated with aging.
The deterioration of the perivaginal muscles contributes to a number of medical conditions including uterine prolapse, fallen bladder, fallen rectum, cystitis, difficulties with voiding, decreased sexual comfort, chronic vaginal and lower back discomfort, and various forms of incontinence. Many of these medical conditions are curable only through heavy medication or costly and painful surgery; however, proper perivaginal muscle tone has been shown to significantly reduce the occurrences of many of the above mentioned medical conditions. Although simply maintaining proper perivaginal muscle tone is an effective method for reducing numerous medical conditions associated with the deterioration of the perivaginal muscles, it appears that the public is unwilling to utilize the current methods and apparatuses for strengthening these particular muscles, as 10 to 35% of female adults suffer from various forms of medical conditions associated with perivaginal muscle deterioration. Incontinence in particular, plagues over 13 million Americans and over one half of the nursing home residents in the United States. These numbers clearly represent the need for a simple device used to exercise and strengthen the perivaginal muscles.
Numerous intravaginal devices for exercising and strengthening the perivaginal muscles have been disclosed in the relevant art, including U.S. Pat. No. 4,895,363, which teaches a Set Of Parts And Methods For Testing And/Or Strengthening The Pelvic Floor Muscles comprising a plurality of cone shaped vaginal inserts having various weights. Utilization of the method disclosed includes insertion of one of the cones, typically a lighter cone first, and attempting to retain the cone within the vagina. If the cone can be retained, it should be replaced with a heavier one until maintaining the cone within the vagina is not easily accomplished. This cone then represents the proper exercise cone to start with. Actual exercising of the pelvic floor muscles involves complete insertion of the cone and contracting the muscles such that the cone is urged inward and upward. This action exercises the muscles when it is repeated. However, this method and apparatus are difficult to properly utilize, as the insert can become lost or lodged within the vagina, improperly placed such that the pelvic floor muscles are not even exercised, and is somewhat psychologically difficult to utilize given these negative possibilities.
Another device disclosed in the relevant art is U.S. Pat. No. 4,241,912 for an Isometric Vaginal Exercise Device And Method. This device utilizes a rounded shaft having flange and handle attached to one end for manipulation, a concave portion of the shaft is positioned proximate the flange such that the diameter of the shaft decreases proximate the flange and then increases to a maximum value as the distance from the flange increases, and the shaft terminates in a decreasing diameter rounded end. The device is inserted within the vagina with only a portion of the handle protruding from the vagina, such that the device can be manipulated by the user. The device is to be placed such that the perivaginal muscles are proximate the concave portion of the shaft, thereby facilitating gripping of the device by the particular muscles and allowing for exercise. Exercise is accomplished with this device through the movement of the pelvic floor muscles up and down on the rounded end of the device. The device remains stationary within the vagina. This device, in similar fashion to the previously mentioned apparatus, is again difficult to properly utilize given the possibility of improperly placing the device such that the perivaginal muscles are not properly exercised, along with the psychological difficulties associated with the use of the device.
Aside from vaginal exercise inserts, physicians have attempted to utilize medication in an attempt to cure the problems associated with poor perivaginal muscle strength. However, there are specific disadvantages associated with medication type cures also. These types of cures typically do not increase the strength of the relevant muscles, they only temporarily relieve the resulting symptoms associated with poor muscle strength. Medications for incontinence, for example, often offer only temporary relief to the patient until muscle strength can be restored through exercise. Incontinence medications, in addition to being only a temporary cure, can also further the symptoms by medically causing the muscles to further relax, thus reducing the urethra's ability to resist or maintain fluid flow.
Therefore, although numerous methods and devices currently exist for exercising the perivaginal muscles, the methods and devices currently used are seldom used properly or adhered to for a time period significant enough to benefit the patient. This is likely due to the physical shortcomings of the above mentioned devices, in addition to the inherent psychological objections involved with using any vaginally inserted device. The size, complexity, and methods of use of the devices currently in the art are certain to increase these objections, thus reducing the effectiveness of the devices. Additionally, the complexities involved with cleaning, transporting, and general use of these devices also hinder the effectiveness of the methods and devices. In order for the current devices to be effective, they must not only be regularly used for a significant period of time, typically three to six months, but they also require physician instruction in order to properly utilize the device.